FDA Drug Recalls

1,739 recalls · Class I, newest first

Class I · High risk Terminated Nov 18, 2013

MaXtremeZEN capsules, 1 capsule per blister pack, Distributed by: P&A Enterprise, Buena Park, CA 90621, UPC 6 10079 52468 2.

Reason Marketed Without An Approved NDA/ANDA: FDA analysis found MaXtremeZEN which is marketed as a dietary supplement to contain undeclared desmethyl…

SS Wholesale Inc. dba Jobbers Wholesale D-1046-2014

Class I · High risk Terminated Nov 18, 2013

Rhino 5 capsules(Spanish & English Labeling), 1 capsule per blister pack, Distributed by P&A Enterprise, Buena Park, CA 90621…

Reason Marketed Without An Approved NDA/ANDA: FDA analysis found Rhino 5 which is marketed as a dietary supplement to contain undeclared desmethyl…

SS Wholesale Inc. dba Jobbers Wholesale D-1045-2014

Class I · High risk Terminated Nov 13, 2013

Glycopyrrolate (MDV) 0.2 MG/ML Injectable, 5 mL Vials, Sterile Serum Vials/Sterile Syringes, for use by a licensed professional…

Reason Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis.

Brookfield Prescription Center Inc D-1252-2014

Class I · High risk Terminated Nov 7, 2013

Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Dietary Supplement, www.adipotrim.com.

Reason Marketed Without an Approved NDA/ANDA: FDA lab results found undeclared API Fluoxetine in this dietary supplement.

Deseo Rebajar D-1277-2014

Class I · High risk Terminated Nov 4, 2013

Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade, 45 capsules per bottle, Dietary Supplement…

Reason Marketed Without an Approved NDA/ANDA; this product is being recalled for containing an undeclared diuretic called Triamterene, an FDA approved…

IQ Formulations, LLC D-1050-2014

Class I · High risk Terminated Nov 4, 2013

Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx…

Reason Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.

Alexion Pharmaceuticals, Inc. NDC 25682-001-01 D-1049-2014

Class I · High risk Terminated Oct 21, 2013

Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For use and distribution in prescription compounding…

Reason Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was found on the label.

Medisca Inc. NDC 38779-2673-1 D-1263-2014

Class I · High risk Terminated Oct 19, 2013

Dextrose* Vial In Sterile Water, 50%, 50 mL Single Dose Vial, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette…

Reason Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold, was found floating in the product.

Specialty Medicine Compounding Pharmacy, P.C. D-1156-2014

Class I · High risk Terminated Oct 18, 2013

Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per…

Reason Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be…

Hospira Inc. NDC 0409-1559-30 D-1161-2014

Class I · High risk Terminated Oct 15, 2013

Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Delivery System, 1 g in 50 mL duplex container, For IV Use…

Reason Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic…

B. Braun Medical Inc NDC 0264-3193-11 D-1054-2014

Class I · High risk Terminated Oct 10, 2013